Remote medical device alarm

ABSTRACT

A remote alarm for use with a wearable medical device. The remote alarm is configured to receive alarms, voice messages and prompts issued by the wearable medical device and to repeat those alarms, voice messages and prompts in a manner that can more easily be perceived by a patient wearing the wearable medical device or a bystander. The remote alarm can be configured to receive a communication from the wearable medical device, and in response, to identify one or more messages to be provided to the patient or a bystander. The messages may be provided audibly, visually, tactilely or combinations thereof. The remote alarm may further be configured to take certain actions depending upon the content of the communication, such as sending a telephone message to alert emergency personnel to the identity, location and medical condition of the patient, or sending an email.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/665,090 (filed 28 Oct. 2019), which is a continuation of U.S. patentapplication Ser. No. 16/185,123 (filed 9 Nov. 2018, now U.S. Pat. No.10,485,982), which is a continuation of U.S. patent application Ser. No.15/840,014 (filed 13 Dec. 2017, now U.S. Pat. No. 10,159,849), which isa continuation of U.S. patent application Ser. No. 14/579,615 (filed 22Dec. 2014, now U.S. Pat. No. 9,925,387), which is a continuation of U.S.patent application Ser. No. 13/286,533 (filed 1 Nov. 2011, now U.S. Pat.No. 9,937,355), which claims the benefit of U.S. Provisional PatentApplication 61/411,189 (filed 8 Nov. 2010). The disclosures of each ofthe foregoing applications are incorporated herein by reference in theirentirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention is directed to a remote alarm for use with awearable medical device.

2. Discussion of Related Art

During the course of use, a wearable medical device, such as a wearabledefibrillator, a wearable insulin pump, etc., may issue audible alarms,voice prompts or messages, or visual messages to alert the patient or abystander to a medical condition, to direct them to take some action tocorrect a problem, to call for assistance, to request information fromthe patient or the bystander, or to provide feedback to the device sothat the device may continue to function properly. For example, wherethe wearable medical device is a wearable defibrillator, if the devicedetermines that the patient is experiencing cardiac arrhythmia, thedevice may issue alarms and voice messages instructing the patient toindicate that they are conscious by pressing and holding a buttonassociated with the device, thereby instructing the device to withholdthe delivery of a defibrillating shock. If the patient does not respond,the device may presume that the patient is unconscious, and proceed withthe treatment sequence, culminating in the delivery of one or moredefibrillating shocks to the body of the patient. Alarms and messagesmay also be directed to a bystander instructing the bystander to callfor medical assistance, or to alert any bystanders that a defibrillatingshock is about to be delivered and to stand clear of the patient.

SUMMARY OF THE INVENTION

Applicants have appreciated that there may be circumstances where thealarms and messages may not be received by the patient or bystanders.For example, where the patient is asleep in bed, the patient may besleeping so soundly that the alarms and voice messages are not loudenough to wake the patient. Alternatively or additionally, the speakerregion of the wearable medical device may be blocked or shielded bybedding or an article of clothing, thereby reducing the sound to a levelwhere the patient or bystander does not hear the alarms, voice promptsor messages. Even where the patient may be awake, the patient may belocated in a noisy environment, such that they cannot hear the alarms ormessages.

According to an aspect of the present invention, a remote alarm isprovided for use with a wearable medical device. In accordance with oneembodiment, the remote alarm is configured to receive alarms, voicemessages and prompts issued by the wearable medical device and to repeatthose alarms, voice messages and prompts in a manner that can moreeasily be perceived by a patient wearing the wearable medical device ora bystander. In accordance with another embodiment, the remote alarm canbe configured to receive a communication from the wearable medicaldevice, and in response to that communication, to identify one or moremessages to be provided to the patient or a bystander. The messages maybe provided audibly or visually, or both. In certain embodiments, inaddition to providing messages to the patient or bystander, the remotealarm may further be configured to take certain actions depending uponthe content of the communication, such as sending a telephone message toalert emergency personnel to the identity, location and medicalcondition of the patient, or sending an email to a friend or relative.

In accordance with one embodiment of the present invention, a remotealarm is provided for use with a wearable medical device. The remotealarm comprises an RF receiver to receive an RF signal indicative of amessage to be provided by the wearable medical device, an audio circuit,electrically coupled to the receiver, to convert the message to an audiosignal, and an audio display device. The audio display device iselectrically coupled to the audio circuit to receive the audio signaland reproduce the message to be provided by the wearable medical device.In accordance with an aspect of this embodiment, the receiver receivesthe RF signal using one of a Bluetooth, Wireless USB, and a ZigBeecommunication standard, and the message is a voice message, siren, ortone. In accordance with another aspect of this embodiment, the wearablemedical device is a wearable defibrillator. In accordance with a furtheraspect of this embodiment, the message is reproduced at a greater volumethan can be provided by the wearable medical device. In accordance witha further aspect of this embodiment, the remote alarm includes a highintensity light bulb that illuminates in response to receipt of themessage.

In one embodiment, the RF receiver, the audio circuit, the audio displaydevice, and the light bulb are integrated into a first device configuredto be directly plugged into an AC power receptacle. In a furtherembodiment, the remote alarm further comprises a second device, distinctfrom the first device, wherein the second device includes a responsebutton by which a response to the message can be provided, and an RFtransmitter to transmit the response to the wearable medical device. Ina still further embodiment, the remote alarm may further comprise athird device, distinct from the first device and the second device, thethird device including an RF receiver to receive the RF signalindicative of the message to be provided by the wearable medical device,and an electromechanical vibrator configured to vibrate in response toreceipt of the message.

In accordance with another embodiment of the present invention, a remotealarm for use with a wearable medical device is provided. The remotealarm comprises an RF transceiver to receive an RF communication fromthe wearable medical device, a processor, an audio circuit, and an audiodisplay device. The processor is electrically coupled to the RFtransceiver to process the communication and to identify a message basedupon a content of the communication. The audio circuit is electricallycoupled to the processor and configured to convert the message to anaudio signal, and the audio display device is electrically coupled tothe audio circuit and configured to audibly reproduce the message. Inaccordance with one aspect of this embodiment, the message may include atext message, and the audio circuit includes a voice synthesizer that isconfigured to convert the text message to an audio signal, that whenreproduced by the audio display device, corresponds to a speech versionof the text message.

In accordance with another aspect of this embodiment, the message is afirst message, and the remote alarm further comprises at least onecommunication interface that is electrically coupled to the processorand communicatively coupled to a network. The at least one communicationinterface is configured to communicate a second message over the networkin response to receipt of the communication. In accordance with afurther aspect of this embodiment, in response to the content of thecommunication indicating that a patient wearing the wearable medicaldevice is experiencing a medical condition, the processor is configuredto instruct the at least one communication interface to send the secondmessage over the network to emergency personnel. In accordance with anaspect of this embodiment, the at least one communication interfaceincludes at least one of a telephone network interface, a computernetwork interface, and a cellular network interface. In accordance withanother aspect of this embodiment, the processor instructs the at leastone communication interface to communicate the second message over thenetwork to emergency personnel responsive to the content of thecommunication indicating that a patient wearing the wearable medicaldevice is experiencing a medical emergency. In accordance with a furtheraspect of this embodiment, the second message identifies the patient, aphysical location of the patient, and the medical emergency.

In accordance with yet another aspect of this embodiment, the processorfurther instruct the at least one communication interface to communicatea third message over the network to at least one of a caregiver of thepatient and a relative of the patient. In accordance with an aspect ofthe present invention, the wearable medical device can be a wearabledefibrillator.

In accordance with a still further aspect of this embodiment, the remotealarm may include additional circuitry capable of performing otherfunctions, such as a user interface to receive feedback from the patientor a bystander, and a battery charging and conditioning circuit toreceive, charge, and condition a rechargeable battery of the wearablemedical device. In certain embodiments, feedback received from thepatient or a bystander may be transmitted to the wearable medicaldevice. For example, in one embodiment, the remote alarm furthercomprises a user interface, electrically coupled to the processor. Inthis embodiment, the user interface is configured to receive a responseto the message, and the processor send the response to the wearablemedical device via the RF transceiver in response to receipt of theresponse to the message by the user interface. In accordance with afurther aspect of this embodiment, the message is a first message, andthe remote alarm further comprise at least one communication interfacethat is electrically coupled to the processor and communicativelycoupled to a network, the at least one communication interface beingconfigured to communicate a second message over the network in responseto receipt of the communication. In accordance with one embodiment, inresponse to the content of the communication indicating that a patientwearing the wearable medical device is experiencing a medical emergency,and responsive to the remote alarm not receiving any response to themessage, the processor instructs the at least one communicationinterface to communicate the second message over the network toemergency personnel, the second message identifying at least one of thepatient, a physical location of the patient, and the medical emergency.

In accordance with one embodiment, the remote alarm includes a clipconfigured to secure the remote alarm to an ear of a patient wearing thewearable medical device, and in accordance with another embodiment, theremote alarm includes a strap configured to secure the remote alarm to awrist of a patient wearing the wearable medical device.

In accordance with another aspect of the present invention, a method ofremotely alerting a patient wearing a wearable medical device to amedical condition is provided. The method comprises acts of receiving,on a first device that is distinct from the wearable medical device, acommunication from the wearable medical device; processing, on the firstdevice, the communication to identify a message to be communicated tothe patient based upon a content of the communication; determining, onthe first device, whether the message is to be immediately communicatedto the patient; and converting the message to an audio signal andaudibly reproducing the message on the first device to alert the patientto the medical condition in response to a determination that the messageis to be immediately communicated to the patient.

In accordance with one embodiment, the message is a first message, andthe method further comprising acts of waiting, responsive to the act ofconverting and audibly reproducing the first message, a predeterminedperiod of time for a response to the first message; and communicating,over a communication network to which the first device iscommunicatively coupled, a second message to at least one of emergencymedical personnel, a caregiver of the patient, and a relative of thepatient to alert them to the medical condition in response to notreceiving the response to the first message within the predeterminedperiod of time.

In accordance with another embodiment, the method further comprises actsof converting the message to a text message in response to adetermination that the message is not to be immediately communicated tothe patient; storing the text message in a memory of the first device;and setting an indicator on the first device to alert the patient to thestored text message.

In accordance with yet another embodiment, the message is a firstmessage, and the method further comprises an act of sending a secondmessage from the first device to a second device that is distinct fromthe first device and the wearable medical device, the second messageinstructing the second device to vibrate in response to receipt of thesecond message to alert the patient to the medical condition.

Still other aspects, embodiments, and advantages of these exemplaryaspects and embodiments, are discussed in detail below. Moreover, it isto be understood that both the foregoing information and the followingdetailed description are merely illustrative examples of various aspectsand embodiments of the present invention, and are intended to provide anoverview or framework for understanding the nature and character of theclaimed aspects and embodiments. Any embodiment disclosed herein may becombined with any other embodiment in any manner consistent with atleast one of the objects, aims, and needs disclosed herein, andreferences to “an embodiment,” “some embodiments,” “an alternateembodiment,” “various embodiments,” “one embodiment,” “at least oneembodiment,” “this and other embodiments” or the like are notnecessarily mutually exclusive and are intended to indicate that aparticular feature, structure, or characteristic described in connectionwith the embodiment may be included in at least one embodiment. Theappearance of such terms herein is not necessarily all referring to thesame embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, each identical or nearly identical component that isillustrated in various figures is represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing. In the drawings:

FIG. 1 illustrates a wearable medical device, such as a wearabledefibrillator and an associated base unit;

FIG. 2 is a functional block diagram of remote alarm that may be usedwith a wearable medical device in accordance with an aspect of thepresent invention;

FIG. 3 illustrates a remote alarm that may be used with a wearablemedical device in accordance with an aspect of the present invention inwhich the remote alarm includes a number of discrete alarm devices; and

FIG. 4 illustrates several alternative embodiments of a remote alarm inaccordance with aspects of the present invention.

DETAILED DESCRIPTION

This invention is not limited in its application to the details ofconstruction and the arrangement of components set forth in thefollowing description or illustrated in the drawings. The invention iscapable of other embodiments and of being practiced or of being carriedout in various ways. Also, the phraseology and terminology used hereinis for the purpose of description and should not be regarded aslimiting. The use of “including,” “comprising,” “having,” “containing,”“involving,” and variations thereof herein is meant to encompass theitems listed thereafter and equivalents thereof as well as additionalitems.

FIG. 1 illustrates a wearable medical device 100 and an associated baseunit 130. In the embodiment depicted in FIG. 1, the wearable medicaldevice 100 is a wearable defibrillator, such as a LifeVest® wearablecardioverter defibrillator available from Zoll Medical Corporation ofChelmsford, Mass. As shown, the wearable medical device 100 includes aharness 110 having a pair of shoulder straps and a belt that is wornabout the torso of a patient. The wearable medical device 100 includes aplurality of ECG sensing electrodes 112 that are attached to the harness110 at various positions and electrically coupled to a control unit 120.The wearable medical device 100 also includes a plurality of therapyelectrodes 114 that are electrically coupled to the control unit andcapable of delivering one or more therapeutic defibrillating shocks tothe body of the patient, if it is determined that such treatment iswarranted. Although not shown, the wearable medical device 100 mayinclude additional sensors, other than the ECG sensing electrodes 112,capable of monitoring the physiological condition or activity of thepatient. For example, sensors capable of measuring blood pressure, heartrate, thoracic impedance, pulse oxygen level, respiration rate, heartsounds, and the activity level of the patient may also be provided.

In use, the control unit 120 of the wearable medical device 100 monitorsECG signals provided by the plurality of ECG electrodes 112 and, whereprovided, some or all of the signals provided by other sensors. Wherethe control unit 120 determines that the patient is experiencing cardiacarrhythmia, the control unit 120 may issue an audible alarm via aloudspeaker (not shown) on the control unit 120 or on the harness 110alerting the patient and any bystanders to the patient's medicalcondition. The control unit 120 may also instruct the patient to pressand hold a button (not shown) on the control unit 120 or elsewhere toindicate that the patient is conscious, thereby instructing the controlunit 120 to withhold the delivery of one or more therapeuticdefibrillating shocks.

As shown in FIG. 1, the wearable medical device 100 may be associatedwith a base unit 130. For example, in the LifeVest® wearablecardioverter defibrillator, a base unit 130 is provided that is capableof performing a number of different functions. One of the functionsperformed by the base unit 130 is to charge an auxiliary battery that isused to provide power to the wearable medical device. The LifeVest®wearable cardioverter defibrillator is provided with two batteries, suchthat one of the batteries is recharged while the other is providingpower to the device. When the battery that is providing power to thedevice needs recharging, it is swapped with the auxiliary battery, andrecharged, with this cycle being repeated throughout the duration ofpatient usage. Another of the functions performed by the base unit 130is to store and/or communicate information received from the wearablemedical device over a wired or wireless communication network. Forexample, information relating to the patient's medical condition over aperiod of time may be communicated by the base unit 130 to a medicalservice provider, such as a doctor, so that the doctor may remotelymonitor the patient's medical condition. The information received by thebase unit 130 may be communicated over the network shortly after it isreceived by the base unit 130, or alternatively, may be stored in amemory of the base unit 130 and communicated over the network at a latertime. The information that is communicated by the base unit 130 may beretained in the memory of the base unit.

The base unit 130 includes a visual display 131 that can communicatevisual messages to the patient or a bystander, an audio output device134, such as a loudspeaker, that can communicate audible messages to thepatient or a bystander, and a plurality of buttons 133 by which thepatient or a bystander can communicate with the base unit 130. Incertain embodiments, the visual display 131 may include a touch screendisplay, such that the patient or a bystander may also communicate withthe base unit via the visual display 131. The base unit 130 includes atleast one charging bay 132 to receive a rechargeable auxiliary battery,such as a three cell 2200 mAh lithium ion battery pack, that can be usedto provide power to the wearable medical device 100. The base unit 130also includes several different communication interfaces including: adevice communication interface 138 to receive information from thecontrol unit 120 of the wearable medical device, a telephone networkinterface 136 to communicate, via a telephone network, the informationreceived from the wearable medical device, and a network interface 137to communicate, via a wired network connection, the information receivedfrom the wearable medical device. In certain embodiments, the base unit130 also includes an antenna 135 that can wirelessly communicate theinformation received from the wearable medical device via a cellular(e.g., 2G, 3G, and 4G) network.

FIG. 2 illustrates a remote alarm 200A, 200B that may be used with awearable medical device 300, such as a wearable defibrillator, awearable insulin infusion pump, or any other type of wearable medicaldevice in accordance with an aspect of the present invention. Thewearable medical device 300 generally includes at least one processor,microprocessor, or controller 310, such as a processor commerciallyavailable from companies such as Texas Instruments, Intel, AMD, Sun,IBM, Motorola, Freescale and ARM Holdings. In one exemplary embodimentdirected to a wearable defibrillator, the at least one processor 310 mayinclude a power conserving processor arrangement that includes a generalpurpose processor, such as an Intel® PXA270 processor and a specialpurpose processor, such as a Freescale DSP56311 Digital SignalProcessor, as described in co-pending application Ser. No. 12/833,096,entitled SYSTEM AND METHOD FOR CONSERVING POWER IN A MEDICAL DEVICE,filed Jul. 9, 2010 (hereinafter the “'096 application”) and incorporatedby reference herein in its entirety. The at least one processor 310 iselectrically coupled to a plurality of sensors 325, such as ECG sensingelectrodes 112 and therapy electrodes 114 (FIG. 1) to monitor thepatient's medical condition, and in some embodiments, to provide medicaltreatment to the patient in response to a detected medical condition,such as cardiac arrhythmia.

In accordance with an aspect of the present invention, the wearablemedical device 300 also includes a wireless Radio Frequency (RF)transceiver 320 that is electrically coupled to the at least oneprocessor 310 and capable of wirelessly and bi-directionallycommunicating with the remote alarm 200A, 200B. In certain embodiments,the wireless RF transceiver 320 may communicate with the remote alarm200A, 200B using a wireless communication standard and protocol that isoptimized for low cost and shorter distance (e.g., 10 meters)communications, such as Bluetooth, Wireless USB, or ZigBee. In otherembodiments, the RF transceiver 320 may communicate with the remotealarm 200A, 200B using a communication standard and protocol capable ofcommunicating over greater distances, such as Wireless Ethernet, or GSM.For example, in one embodiment, the RF transceiver 320 may communicatevia wireless Ethernet with a large format display device, such as atelevision or an Ipad® to display status, alerts or reminderscommunicated by the wearable medical device. In certain embodiments,where low cost is a concern, or where communication in only onedirection is desired, the wireless RF transceiver 320 may be replacedwith a wireless RF transmitter capable of transmitting an analog signal.Although the wireless medical device 300 would not be able to receivemessages from the remote alarm 200A, 200B, this embodiment would stillbe capable of sending information to the remote alarm over a wirelesscommunication channel as discussed further below.

In accordance with one embodiment of the present invention, the remotealarm 200A, 200B may be implemented as a low-cost device with a singularpurpose of being a remote bed-side or table-top alarm that is capable ofrepeating alarms, voice prompts, and messages issued by the wearablemedical device. A functional block diagram of such a single purpose,low-cost, remote alarm is identified in FIG. 2 by reference designator200A. In an alternative embodiment, the remote alarm 200A, 200B mayinclude additional functionality, such as, for example, the ability toreceive, charge and condition one or more auxiliary rechargeablebatteries, the ability to function as an alarm clock, the ability toreceive and store information indicative of the patient's medicalcondition, the ability to communicate information, including informationindicative of the patient's medical condition, to a medical serviceprovider, to a friend or relative, or to emergency personnel over awired, wireless, or telephone network, etc. A functional block diagramof such a multi-function remote alarm is identified in FIG. 2 byreference designator 200B. Each of these embodiments is now described indetail below.

The remote alarm 200A includes a wireless RF receiver 220 that iselectrically coupled to an audio circuit 230, which is, in turn,electrically coupled to an audio output device 235, such as aloudspeaker. The wireless RF receiver 220 is capable of receiving ananalog RF signal from the wearable medical device 300 that carries thesame information as that which would be provided to audio circuitryincluded in the wearable medical device. The information received by theRF receiver 220 is provided to the audio circuit 230 that converts thereceived information to an audio signal capable of being reproduced bythe audio output device 235. In this embodiment, the remote alarm 200Asimply repeats the same alarms, voice prompts, and voice messages thatwould be provided by the wearable medical device 300. However, becausethe remote alarm 200A may be placed in a location where it will not beblocked by bedding, clothing, or other obstructions, and because theaudio output device can be larger than that on the wearable medicaldevice, the sound emitted by the remote alarm 200A will be louder thanthat provided by the wearable medical device 300 and more likely to beheard by the patient or any bystander. It should be appreciated thatrather than transmitting an analog RF signal to the remote alarm 200A, adigital RF signal may be used instead. However, the use of digitalcommunication may require additional circuitry, such as aDigital-to-Analog converter, which may be avoided by using an analog RFtransmission where cost is a paramount concern.

The remote alarm 200B is capable of performing functions in addition tothose described with respect to remote alarm 200A, and may be integratedinto a base unit, such as the base unit 130 described with respect toFIG. 1. The remote alarm 200B includes a processor 210 that iselectrically coupled to a wireless RF transceiver 221 and an audiocircuit 231, with the audio circuit 231 being electrically coupled to anaudio output device 235, such as a loudspeaker. The remote alarm 200Balso includes a memory 280, such as RAM, ROM, or Flash memory that iselectrically coupled to the processor 210. Although the memory 280 isshown as being separate from the processor, it should be appreciatedthat certain commercially available processors may include the memory onthe same integrated circuit as the processor 210. Moreover, the memory280 may include other types of memory, such as magnetic disk memory,optical memory, a USB jump drive, etc. The processor 210 may be anygeneral purpose or special purpose processor available from companiessuch as Texas Instruments, Intel, Sun, AMD, IBM, Motorola, etc.

The wireless RF transceiver 221 is capable of wirelessly andbi-directionally communicating with the wearable medical device 300, andmay include any type of transceiver that is compatible with thecommunication standard and protocol used by the transceiver 320 of thewireless medical device 300, such as Bluetooth, Wireless USB, ZigBee,etc. In certain embodiments, where low cost is a concern, or wherecommunication in only one direction is desired, the wireless RFtransceiver 221 may be replaced with a wireless RF receiver, such asthat described above with respect to remote alarm 200A, such that theremote alarm 200B can receive messages and alarms transmitted by thewearable medical device, but cannot send communications back to thewearable medical device 300. The audio circuit 231 may be any audiocircuit capable of providing an audio signal to the audio output device235. In certain embodiments, the audio circuit 231 may include a voicesynthesizer capable of converting text messages to audible voicemessages.

In accordance with certain embodiments of the present invention, theremote alarm 200B may include additional circuitry to implementadditional functionality. For example, the remote alarm 200B may includea plurality of communication interfaces, such as a telephone networkinterface 240 by which the remote alarm 200B can communicate over atelephone network, a wired or wireless computer network interface 250 bywhich the remote alarm 200B can communicate over a computer network, anda cellular network interface 260 by which the remote alarm 200B cancommunicate over a cellular (e.g., 2G, 3G, 4G) network. Other circuitrythat may be included in the remote alarm 200B may include a batteryrecharging and conditioning circuit 270 capable of conditioning andrecharging one or more rechargeable batteries that can be used toprovide power to the wearable medical device 300, and a user interface290. The user interface 290 may include a visual touch screen display bywhich the patient or a bystander can communicate with the remote alarm200B, and may include a plurality of buttons and/or LEDs, or even acomputer keyboard connector for attachment of a computer keyboard to theremote alarm 200B. The visual touch screen display may function as aclock or as an alarm clock when not otherwise communicating with thepatient or a bystander, or alternatively, a separate display may beprovided to implement alarm clock functionality.

In accordance with one embodiment of the present invention, thefunctionality of the remote alarm 200B may be similar to that providedby the wearable medical device 300. For example, in one embodiment, theremote alarm 200B may receive the same information provided to audiocircuitry on the wearable medical device 300 and simply repeat thosealarms, voice messages, and voice prompts. Where the patient orbystander does not respond, the remote alarm may be programmed to repeatthe alarm, voice message, or prompt, but at a louder volume. Suchfunctionality may be sufficient to get the patient's attention, evenwhere the patient is located in a noisy environment, asleep, or both.

In accordance with another embodiment of the present invention, theremote alarm 200B can be capable of providing feedback to the wearablemedical device 300. For example, in one embodiment, in response to analarm, voice message or prompt, the patient or a bystander maycommunicate with the wearable medical device 300 via the user interface290 on the remote alarm 200B. The patient could thereby acknowledge thatthe alarm, voice prompt, or voice message was received by pressing abutton on the remote alarm 200B, or by interacting with the touch screenon the remote alarm. The remote alarm 200B could then transmit thatacknowledgement to the wearable medical device 300 via the transceiver221. In certain embodiments, the remote alarm 200B can include softwareand/or hardware capable of determining whether the acknowledgement ofthe alarm, voice prompt, or message is provided by the patient, or byanother. For example, the remote alarm 200B can include voicerecognition functionality capable of recognizing the patient's voice, orthat of a loved one or caretaker as described in co-pending U.S. patentapplication Ser. No. 12/082,168, entitled WEARABLE DEFIBRILLATOR WITHAUDIO INPUT/OUTPUT, which is herein incorporated by reference in itsentirety. Alternatively, the remote alarm 200B can include hardwareand/or software to recognize biometric information of the patient (orthat of a loved one or caretaker), such as capacitance, ECG signals, ormarkers or ID signals, as described in co-pending U.S. patentapplication Ser. No. 12/150,720, entitled MEDICAL DEVICE CONFIGURED TOTEST FOR USER RESPONSIVENESS, which is herein incorporated by referencein its entirety.

In accordance with another embodiment of the present invention, theremote alarm 200B can be capable of providing enhanced communicationsrelative to those afforded by the wearable device 300. For example,rather than transmitting the same information to the remote alarm 200Bthat wearable medical device 300 provides to its audio circuitry, thewearable device 300 could communicate a code to the remote alarm 200Bthat corresponds to a particular alarm, message, or prompt stored in amessage table in the memory 280 of the remote alarm 200B. The codetransmitted to the remote alarm 200B could be in analog form, ordigital. On receipt of the code, the processor 210 could access themessage table and communicate the message to the patient or bystander.The message could be stored in the message table in text form andconverted to speech by a voice synthesizer in the audio circuit 231 ofthe remote alarm 200B. Alternatively, the message could be displayed intext form on the touch screen display, either alone, or in combinationwith the message being reproduced audibly. The code could identify thecontent and or length of the message, prompt or alarm to be communicatedto the patient or bystander, as well as the loudness of the message, andwhat actions are to be taken in the event of a particular response, orlack of response, from the patient or bystander.

For example, where the wearable medical device 300 is a wearabledefibrillator, in the event that the wearable medical device detects acardiac arrhythmia and the patient does not respond to indicate they areconscious, the remote alarm 200B can place a phone call to emergencypersonnel (e.g., 911). The remote alarm 200B can then play apre-recorded message that may be stored in the memory 280 to identifythe name of the patient, their location, and the detected medicalcondition. The remote alarm 200B can also notify the patient's medicalservice provider to alert them to the patient's condition and thatemergency services have been called, and also inform a loved one orrelative. The names of the various contacts and the content of themessages to be sent can be stored in the memory 280 of the remote alarm200B during a set-up procedure. The patient's medical service providerand the patient's loved one or relative can be sent an email or textmessage via the wired or wireless computer network interface 250, orcontacted by telephone after notifying emergency personal using eitherthe telephone network interface 240 or the cellular network interface260 and playing a pre-recorded message.

Other enhanced communications that may be provided by the remote alarm200B can include the ability to communicate messages in differentlanguages. For example, the user interface 290 of the remote alarm 200Bcan permit a first language (e.g., the patient's native language) to beselected and used for communicating with the patient, and a secondlanguage, different than the first language, to be selected and used forcommunicating with others, such as bystanders or emergency personnel.Such a feature would be appropriate for those instances where thepatient speaks one language, but is physically present in a geographiclocation where the language spoken by the patient is not native to thegeographic location. Where the remote alarm 200B includes an ability todetect its geographic location (e.g., GPS capability), the remote alarmmay automatically configure itself to use the language native to thatgeographic location for communications directed to a bystander oremergency service personnel.

In accordance with one embodiment, the remote alarm 200B is capable ofcommunicating various information to the patient, a bystander, acaregiver or a loved one in different ways, depending on the type ofinformation being communicated, or depending on the manner in which theremote alarm is programmed to communicate such information. For example,where the information to be communicated to the patient is of an urgentnature, the remote alarm 200B may immediately communicate thisinformation to the patient via the audio output device 235, alone or incombination with other types of notification (e.g., by energizing avibrating alarm disposed on or near the patient's body as discussedfurther below). Where the wearable medical device 300 is a wearabledefibrillator, such information that may be considered to be of anurgent nature can include a warning message of imminent shock based upona detected arrhythmia, a warning message identifying that therechargeable battery that is powering the wearable medical device 300 iscritically low on charge, a warning message that a sufficient number ofsensors have fallen off or lost contact with the patient's body suchthat the patient may not be protected, etc. Where no response isprovided by the patient, the remote alarm may increase the volume of thealarm, voice message, or prompt, as well as perhaps notify emergencypersonnel, a caregiver, or a loved one. Where the patient is mentallyimpaired, alarms or other messages may be communicated immediately to acaregiver.

Alternatively, where the information to be communicated to the patientis important, but not of an urgent nature, other forms of communicationmay be more appropriate. For example, where the wearable medical device300 is a wearable defibrillator and the information to be communicatedto the patient corresponds to a detected arrhythmia that abated before awarning message of imminent shock was to be delivered, the remote alarmmay simply store the information in the memory 280 and set an indicator(e.g., such as an LED) of the user interface 290 to prompt the patientto interface with the remote alarm 200B and retrieve that informationwhen next possible. Even where an arrhythmia was detected and atherapeutic shock delivered, the patient may be unaware of this fact. Bybeing prompted to retrieve such information, the patient may be madeaware of such events. The occurrence of such events may also becommunicated, for example via email, text, or voicemail to the patient,a loved one, a caregiver, or a medical service provider to alert them tothe occurrence of the event. Other types of information that may beimportant but not urgent for a wearable defibrillator to communicate tothe patient (or a caregiver) can include a poor signal to noise ratio onone or more sensors (but fewer than a sufficient number of sensorsneeded to protect the patient), a detected fall-off of one or moresensors (but again, fewer than a sufficient number of sensors), a lowbattery condition that is not below that needed to monitor and protectthe patient, a warning that the harness 110 (FIG. 1) of the wearablemedical device may need to be laundered to restore its fit, etc. Forother types of wearable medical devices, including defibrillators,messages that are important, but perhaps not urgent, can includereminders about taking medications, a reminder to take a blood glucosereading at a particular time, a reminder to change a battery or anotification that a normal battery replacement or change time has beenmissed, etc.

In accordance with an aspect of the present invention, the patient or acaregiver may use the user interface to set what types of messagesshould be communicated immediately versus those that can wait till thenext time the patient interacts with the remote alarm. Such settings maybe modified based on the time of day and the patient's schedule. Forexample, those messages that might not be necessary to be communicatedimmediately when the patient is asleep may be programmed to becommunicated immediately where the time of day is such that the userwould be awake. Via the user interface, the patient, a caregiver, amedical service provider, or a service technician may set reminders totake medication, reminders to change or recharge a battery, etc., andassign a priority rating to each type of event. Default settings may beprovided, that may be altered via the user interface 290. Other settingsmay be provided to indicate whether the communication should be audible,tactile, or both, and whether people other than the patient (e.g., aloved one or caregiver) should be notified.

In accordance with a further aspect of the present invention,information may be pushed to the remote alarm by the patient'scaregiver, by the patient's medical service provider, by a loved one, orby a service organization associated with the wearable medical device.For example, where the service organization or manufacturer of thewearable medical device has a message about the device for the patient(e.g., a product recall, a product update, etc.), a message may bepushed to the device for later review by the patient at the nextpossible timeframe. Alternatively, a message from the patient's medicalservice provider or a loved one may be pushed to the remote alarm, suchas, for example, a reminder about a medical appointment, etc.

Although each of the remote alarms 200A, 200B has been described hereinas including an RF receiver 220 or transceiver 221 to receive an RFsignal from the wearable medical device 300, it should be appreciatedthe present invention is not so limited. For example, in an alternateembodiment, the remote alarm may simply include a microphone capable ofreceiving alarms, voice prompts and messages issued by the wearablemedical device and an audio circuit and speaker capable of repeatingthose alarms, voice prompts and messages, for example, at a loudervolume. Alternatively still, the communication between the wearablemedical device 300 and the remote alarm 200A, 200B could be infrared,audio, or sub-audio. Moreover, although the remote alarms 200A, 200B areshown as integrated devices, it should be appreciated that variousfunctionality of the remote alarms 200A, 200B may be distributed amongstvarious individual devices that together provide the describedfunctionality. For example, FIG. 3 illustrates a remote alarm 400 thatincludes a number of discrete devices 410, 420, 430, and 440 that maycollectively operate as a remote alarm. As shown in FIG. 3, in oneembodiment, the remote alarm 400 includes an AC receptacle alarm unit410 that is configured to be plugged directly into a conventional wallpower outlet, a vibrating alarm unit 420 that is configured to be placedadjacent to the patient in the patient's bed or armchair, or beneath themattress of the patient's bed or a seat or back cushion of the patient'sarmchair, a remote response button 430 that is configured to be placedin any location convenient for the patient, such as on the nightstandnext to the patient's bed, or adjacent the patient, and an alarm pendant440 that is configured to be worn by a loved one or a caregiver of thepatient.

As shown in FIG. 3, the AC receptacle alarm unit 410 includes an RFantenna 411 by which it can receive messages from the wearable device300 and transmit information back to the wearable device. Although notshown, the AC receptacle alarm unit 410 may include a second antennacapable of communicating (e.g., via a cellular or wireless network) witha medical service provider or emergency personnel. The AC receptaclealarm unit 410 also includes an audio output device 413, such as aloudspeaker, an audio input device 415, such as a microphone, a light417, and a plurality of contacts 419 configured to be received in thewall power outlet. It should be appreciated that the AC receptacle alarmunit may be modified for use with a DC wall outlet. In accordance withan aspect of this embodiment, in response to an urgent message requiringthe immediate attention of the patient or another, the AC receptaclealarm unit 410 may not only audibly communicate the message, but mayalso illuminate the light 417, which may be a high intensity lightbright enough to awaken a sleeping patient (e.g., equivalent inintensity to a 60 watt incandescent bulb, or greater). Although notshown, the AC receptacle alarm unit 410 may include a charging baycapable of receiving and charging an auxiliary battery unit.

The vibrating alarm unit 420 is configured to be placed adjacent thepatient, or in any other location (such as beneath a mattress upon whichthe patient sleeps, or beneath or behind a cushion of an arm chair inwhich the patient reposes) where its vibration would be likely to alertthe patient, if the patient is conscious. The vibrating alarm unit 410includes an antenna 421 to receive information from the wearableambulatory device 300 (FIG. 2), and/or the AC receptacle alarm unit 410,and an electro-mechanical vibrator, such as a piezoelectric vibrator.

The remote response button 430 is configured to be disposed in anyconvenient location where the patient can access the remote responsebutton, and thereby send a signal to the wearable medical deviceindicating that the patient is conscious. As shown, the remote responsebutton 430 includes an antenna 431 for receiving communications from thewearable medical device or the AC receptacle alarm unit 410, and fortransmitting a signal to the wearable device and/or the AC receptaclealarm unit indicating the patient's consciousness. Although not shown,the remote response button 430 may include an audio output device, suchas a loudspeaker, and audio circuitry to repeat the same alarms, voiceprompts, and voice messages that would be provided by the wearablemedical device. Although the remote response button 430 is described asbeing one of the discrete devices of the remote alarm 400, it should beappreciated that both the remote response button 430 and the ACreceptacle alarm unit 410 may be used as standalone devices.

The alarm pendant 440 is configured to be worn about the neck of acaregiver or loved one, and may light, vibrate, or emit an audible soundalerting the caregiver to check on the patient in the event that anevent requiring their attention has been detected. Although not shown,the alarm pendent would also include an RF antenna capable of receivingRF communications, such as Bluetooth, Wireless USB, or ZigBee.

FIG. 4 illustrates two alternative embodiments of a remote alarm inaccordance with aspects of the present invention in the form of anearpiece remote alarm 510 and a watch monitor remote alarm 520. Theearpiece remote alarm 510 includes a clip 511 configured to be disposedabout the patient's ear, and a control module 512 that includes an RFtransceiver, such as a Bluetooth transceiver. Although not visible, inFIG. 4, the earpiece remote alarm 510 includes an audio output device,such as a speaker configured to be disposed proximate the patient's earcanal for audibly communicating messages received from the wearablemedical device 300 to the patient. The earpiece remote alarm may furtherinclude a microphone, such that the earpiece remote alarm mayadditionally act as a hearing aid in which sounds received by themicrophone are amplified and conveyed to the patient. As the human earis considered to be a relatively good location at which to measure thepulse oxygen level of a patient, the earpiece remote alarm 510 mayinclude a pulse oxygen sensor (not shown) that monitors the patient'spulse oxygen level and communicates this information to the wearablemedical device 300 (FIG. 2). In some embodiments, the earpiece remotealarm may include a response button 513 by which the patient mayindicate their consciousness in response to a detected cardiacarrhythmia and warning of imminent shock.

The watch monitor remote alarm 520 resembles an ordinary wristwatch andis configured to be disposed about the patient's wrist using a strap ina conventional manner. The watch monitor remote alarm may, for example,be based upon a watch monitor reference platform, such as the eZ430Chronos Wireless Watch, available from Texas Instruments. As shown, thewatch monitor remote alarm 520 includes a display 521 which can displaythe date and time, and operate as a conventional wristwatch/alarm using,for example, buttons 524 and 525 for programming the date and time, andsetting any alarms. The display 521 can also display informationalmessages or prompts communicated by the wearable medical device 300(FIG. 2). For example, as shown in FIG. 4, the display 521 may display aheart symbol to indicate that no arrhythmias are currently detected, andmay indicate the state of charge of the battery unit associated with thewearable medical device. Although not shown, the watch monitor remotealarm 520 may include an RF transceiver to receive messages, prompts,and other information from the wearable medical device 300, and tocommunicate information back to the wearable medical device. Forexample, where the wearable medical device detects a cardiac arrhythmiaand issues a warning that a shock is imminent, the patient may press andhold a response button 526 to indicate that they are conscious. Thewatch monitor remote alarm 520 may again include functionality todetermine whether the response button 526 was actuated by the patient,or by another. Communication standards supported by the watch monitorremote alarm can include Bluetooth, Wireless USB, ZigBee, as well aswireless Ethernet. The watch monitor remote alarm 520 can include anaudio output device (not shown) by which alarms or audible messages maybe communicated to the patient. The watch monitor remote alarm may alsoinclude sensors (disposed on the back side of the watch and not visiblein FIG. 4) to detect the patient's pulse rate, temperature, or bloodoxygen level, which may be displayed on the display 521. Suchinformation may be displayed by using scrolling buttons 522 and 523.

Having thus described several aspects of at least one embodiment of thisinvention, it is to be appreciated various alterations, modifications,and improvements will readily occur to those skilled in the art. Suchalterations, modifications, and improvements are intended to be part ofthis disclosure, and are intended to be within the scope of theinvention. Accordingly, the foregoing description and drawings are byway of example only.

What is claimed is: 1-28. (canceled)
 29. A cardiac monitoring andtreatment system for providing medical or device notifications to apatient, the system comprising: a wearable cardioverter defibrillatorworn by the patient, the wearable cardioverter defibrillator configuredto detect a treatable cardiac condition in the patient and deliver atherapeutic shock to treat the treatable cardiac condition, wherein thewearable cardioverter defibrillator comprises a first response buttonthat, when actuated, causes the wearable cardioverter defibrillator towithhold delivery of the therapeutic shock; and a remote devicecomprising a memory, a communication interface configured to communicatebidirectionally with the wearable cardioverter defibrillator, an audiooutput device, a second response button that, when actuated, causes thewearable cardioverter defibrillator to withhold delivery of thetherapeutic shock to the patient, and a processor that is coupled to thememory, the communication interface, the audio output device, and thesecond response button, wherein the processor is programmed to receive acommunication from the wearable cardioverter defibrillator, determinewhether the received communication is an urgent communication, and inresponse to determining that the received communication is an urgentcommunication, cause the audio output device to provide a notificationbased on the received communication.
 30. The system of claim 29, whereinthe processor of the remote device is programmed to, in response todetermining that the received communication is not an urgentcommunication, store the received communication in the memory.
 31. Thesystem of claim 30, wherein: the remote device further comprises avisual indicator; and the processor is further programmed to, inresponse to determining that the received communication is not an urgentcommunication, activate the visual indicator to indicate to the patientthat the communication was received.
 32. The system of claim 29, whereinthe remote device is configured to repeat a message issued by thewearable cardioverter defibrillator.
 33. The system of claim 32, whereinthe message is an alarm issued by the wearable cardioverterdefibrillator, and wherein the audio output device is configured torepeat the message at a louder volume.
 34. The system of claim 29,wherein the processor is configured to determine that the receivedcommunication is an urgent communication that was generated in responseto the wearable cardioverter defibrillator detecting the treatablecardiac condition.
 35. The system of claim 34, wherein the notificationcomprises instructions to the patient to actuate at least one of thefirst and second response buttons to indicate that the patient isconscious.
 36. The system of claim 35, wherein the processor isconfigured to cause the audio output device to provide the notificationimmediately upon determining that the received communication is anurgent communication.
 37. The system of claim 34, wherein thenotification comprises instructions to the patient to actuate the secondresponse button to indicate that the patient is conscious.
 38. Thesystem of claim 34, wherein the notification includes a warning messageof imminent shock.
 39. The system of claim 38, wherein the processor isconfigured to cause the audio output device to provide the notificationimmediately upon determining that the received communication is anurgent communication.
 40. The system of claim 29, wherein the remotedevice further comprises an audio circuit configured to convertinformation included in the communication received from the wearablecardioverter defibrillator to an audio signal capable of beingreproduced by the audio output device.
 41. The system of claim 29,wherein the communication interface is configured to communicate withthe wearable cardioverter defibrillator wirelessly.
 42. The system ofclaim 29, wherein: the remote device further comprises a visual touchscreen display by which the patient can provide input to, and receiveinformation from, the remote device; and the second response button is avirtual button displayed on the visual touch screen display.
 43. Thesystem of claim 29, wherein: the remote device further comprises avisual touch screen display by which the patient can provide input to,and receive information from, the remote device; and the visual touchscreen display is further configured to display the communicationreceived from the wearable cardioverter defibrillator.
 44. The system ofclaim 29, wherein: the communication received from the wearablecardioverter defibrillator comprises a code; the processor is furtherconfigured to determine a message by looking up the code in a messagetable that is stored in the memory; and the processor is furtherconfigured to determine whether the received communication is an urgentcommunication based on the determined message.
 45. The system of claim29, wherein: the remote device further comprises an electromechanicalvibrator; and the processor is configured to energize theelectromechanical vibrator in response to determining that the receivedcommunication is an urgent communication.
 46. The system of claim 45,wherein determining that the received communication is an urgentcommunication comprises determining that the received communication wasgenerated in response to the wearable cardioverter defibrillatordetecting the treatable cardiac condition.
 47. The system of claim 29,wherein determining that the received communication is not an urgentcommunication comprises determining that the received communicationcorresponds to a detected arrhythmia that abated before any therapeuticshock was delivered to the patient.
 48. The system of claim 29, whereindetermining whether the received communication is an urgentcommunication at least partially depends on a time of day at which thecommunication was received by the remote device.